Breast CancerNCT07225309
A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer
A study testing Meaning-Centered Psychotherapy for Latinos /MCP-L in people with Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in 2 countries.
Trial summary
The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Colorectal Cancer
- What is being tested?
- Meaning-Centered Psychotherapy for Latinos /MCP-L
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2026to 13 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EMR Criteria
- Documentation of Disease
- Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)
- Definition of Disease [or Measurable Disease]
- Diagnosed with stages III or IV
- Prior Treatment
Show all 20Show fewer
- Receiving ambulatory care at INCan
- Self-Report Criteria
- Age ≥ 18 years
- Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- Providing care (or services) to Mexican cancer patients at INCan
- Has access to internet and an electronic device
- Agrees to be audio-recorded
- Age ≥ 18 years
- Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
- Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
- Providing care (or services) to Mexican cancer patients at INCan
- Has access to internet and an electronic device
- Agrees to be audio-recorded
Who cannot join
- EMR Criteria
- Prior Treatment
- Received psychological or psychiatric care at INCan in the last 3 months
- In the judgment of the treating physician, protocol investigators, and/or study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or study participation
- Diagnosed with a serious psychiatric condition
- Self-Report Criteria
Show all 10Show fewer
- Received psychological or psychiatric care outside of INCan in the last 3 months
- Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale
- Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"
- Provider Eligibility Criteria:
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Devika Jutagir, PhD, 646-888-8361
Devika Jutagir, PhD
Mexico1 site, 1 recruiting
- Not yet recruiting
Instituto Nacional de Cancerología (INCan)
Mexico City
Oscar Galindo Vázquez, psiunigalindo@gmail.com
About this study
Official title: Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer
The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Thyroid Cancer, Breast Cancer Stage III, Breast Cancer Stage IV
- Being tested
- Meaning-Centered Psychotherapy for Latinos /MCP-L
- Keywords
- Breast cancer, Breast cancer Stage III, Breast cancer Stage IV, Prostate cancer, Prostate cancer Stage III, Prostate cancer Stage IV, Colorectal cancer, Colorectal cancer Stage III, Colorectal cancer Stage IV, Thyroid cancer, Thyroid cancer Stage III, Thyroid cancer Stage IV, 25-240, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Colorectal Neoplasms, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Psychotherapy for Latinos /MCP-LBehavioural
MCP-L is a structured 7-session manualized intervention culturally adapted into Spanish for Latino participants diagnosed with advanced cancer, which utilizes a mixture of didactics, discussion and experiential exercises that focus on particular themes related to meaning and advanced cancer. It is 60-minute individual sessions delivered every week or intermittently (depending on participant preference) for up to approximately 3 months (in this time period) in the event of medical illness.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention | Experimental | Meaning-Centered Psychotherapy for Latinos (MCP-L) Receives: Behavioral: Meaning-Centered Psychotherapy for Latinos /MCP-L |
| Control Intervention | No intervention | Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 1-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
Measured: 1 month
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 3-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start1 May 2026
- Primary completion13 Apr 2029 (estimated)
- Study completion13 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devika Jutagir, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225309
- Sponsor's protocol ID
- 25-240
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT07225309
- Acronym / sponsor ID
- 25-240
- Conditions
- Breast Cancer, Prostate Cancer, Colorectal Cancer, Thyroid Cancer, Breast Cancer Stage III, Breast Cancer Stage IV
- Keywords
- Breast cancer, Breast cancer Stage III, Breast cancer Stage IV, Prostate cancer, Prostate cancer Stage III, Prostate cancer Stage IV, Colorectal cancer, Colorectal cancer Stage III
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 13 Apr 2029 (estimated)
- Study completion
- 13 Apr 2029 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention | Experimental | Behavioral: Meaning-Centered Psychotherapy for Latinos /MCP-LMeaning-Centered Psychotherapy for Latinos (MCP-L) |
| Control Intervention | No intervention | –Cognitive Behavioral Therapy (CBT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- EMR Criteria
- Documentation of Disease
- Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)
- Diagnosed with stages III or IV
- Receiving ambulatory care at INCan
Key exclusion criteria (10 listed)
- EMR Criteria
- Prior Treatment
- Self-Report Criteria
- Received psychological or psychiatric care outside of INCan in the last 3 months
- Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meaning-Centered Psychotherapy for Latinos /MCP-LMCP-L is a structured 7-session manualized intervention culturally adapted into Spanish for Latino participants diagnosed with advanced cancer, which utilizes a mixture of didactics, discussion and experiential exercises that focus on particular themes related to meaning and advanced cancer. It is 60-minute individual sessions delivered every week or intermittently (depending on participant preference) for up to approximately 3 months (in this time period) in the event of medical illness. | Behavioural | Experimental Intervention |
Primary outcome
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time frame: 1 month
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 1-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time frame: 3 months
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 3-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devika Jutagir, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning-Centered Psychotherapy for Latinos /MCP-L in people with Breast Cancer and Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devika Jutagir, PhD (646-888-8361, jutagird@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.